Early Defined Processes and a Documented Plan Are Crucial in the Commissioning of GMP Facilities
Commissioning Good Manufacturing Practice (GMP) facilities is a critical yet complex component of the manufacturing sector, especially as facilities grow in sophistication and the standards for quality and safety heighten. Ensuring that clean rooms, HVAC controls, power systems, and other utilities meet stringent requirements is no small feat. Challenges such as permit delays, documentation mismatches, and the alignment of user requirements specifications underscore the need for meticulous planning and execution.
How can manufacturing firms effectively address these issues to uphold and exceed GMP standards?
Nessiem Samuel, the Co-founder and Head of Compliance & Validation at GxP Consulting, offers valuable insights into this question. He emphasizes the importance of a cohesive strategy.
“A defined process and a documented plan that is agreed upon early between the system owner and the execution team are crucial,” Samuel said.
